Pharma (GxP)
Process
- System Analisys (PQLI)
- Process Flow Analisys
- Risk Analisys (GxP/Business)
- Nonconformities structured review and analysis
- Validation Documents wrap up (VP, Protocols, System Description)
- Standard Operating Procedures wrap up
- Test Execution / Supervision
- Audit
- Remediation/Action Plans
- Business Continuity (BS25999)
Validation
- System and Application Software
- Control and Management Systems in pharmaceutical environment (DCS, SCADA, PLC, PID, instrumentation etc.)
- IT Site Infrastructure Network
- Systems/Equipment in Production environment
- Systems/Equipment in Packaging environment
- Systems/Equipment in Laboratory environment
- Building, Utilities e Ancillary
- HVAC
- Wharehouse logistic systems
- Production ancillary systems
- Water Treatment
- Computerized Systems for analitical Laboratory equipment Management & Control
- Computerized Systems for Clinical Data Management
Technical Qualification
- Commissioning (ISPE vol. 5 march 2001)
- FAT (Factory Acceptance Test)
- SAT (Site Acceptance Test)
- Critical Instrumentation Calibration
Training
- Basic Training & Tailored Courses
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Significant work
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